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一种新型尿液肿瘤标志物的分析与临床评估:膀胱肿瘤纤连蛋白在膀胱癌诊断及随访中的应用

Analytical and clinical evaluation of a new urinary tumor marker: bladder tumor fibronectin in diagnosis and follow-up of bladder cancer.

作者信息

Mutlu Nilgun, Turkeri Levent, Emerk Kaya

机构信息

Department of Biochemistry, Marmara University School of Medicine, Haydarpaşa, Istanbul, Turkey.

出版信息

Clin Chem Lab Med. 2003 Aug;41(8):1069-74. doi: 10.1515/CCLM.2003.165.

DOI:10.1515/CCLM.2003.165
PMID:12964816
Abstract

Bladder cancer is the fourth most common malignant neoplasm in men and the tenth most common in women. Cystoscopy presents the gold standard for detection and monitoring of bladder cancer. However, it is an invasive and expensive procedure. Therefore, development of biomarkers for the purposes of screening, diagnosis and prediction of the prognosis in bladder cancer is required. Bladder tumor fibronectin is one of the new urinary tumor markers. The aim of this study is to evaluate the diagnostic performance of urinary bladder tumor fibronectin in detecting and monitoring bladder cancer. A total of 75 patients with the diagnosis of bladder cancer, 20 patients with the diagnosis of benign prostatic hyperplasia, 7 patients with the diagnosis of prostate cancer between the years 1996-2000, and 28 age-matched healthy individuals, were enrolled in the study. The patients were diagnosed by cystoscopy, with histopathological evaluation of the tumor, as having superficial or invasive bladder cancer. Patients were followed-up clinically with data pertinent to disease recurrence and progression. Bladder tumor fibronectin (BTF; ng/ml) was determined by solid phase, two-site chemiluminescent immunometric commercial diagnostic assay developed for the Immulite automated immunoassay system (Diagnostic Products Corporation, Los Angeles, CA, USA). All measured values were normalized by urinary creatinine, and the obtained data were evaluated by receiver-operating characteristics (ROC) curve analysis. Optimal cut-off was established at 43.4 ng/mg. This cut-off rendered overall sensitivities of 72% and specificity of 82.1%. The analytical evaluation of the BTF test displayed promising results in terms of a non-invasive in vitro test in the diagnosis of bladder cancer. Although it was not satisfactory in prediction of recurrence or progression of the disease, it correlated well with the stage, one of the most reliable prognostic factors. In conclusion, the urinary bladder tumor fibronectin test warrants further clinical evaluation.

摘要

膀胱癌是男性中第四常见的恶性肿瘤,在女性中则是第十常见的。膀胱镜检查是检测和监测膀胱癌的金标准。然而,它是一种侵入性且昂贵的检查方法。因此,需要开发用于膀胱癌筛查、诊断和预后预测的生物标志物。膀胱肿瘤纤连蛋白是一种新的尿液肿瘤标志物。本研究的目的是评估尿液膀胱肿瘤纤连蛋白在检测和监测膀胱癌中的诊断性能。1996年至2000年间,共有75例诊断为膀胱癌的患者、20例诊断为良性前列腺增生的患者、7例诊断为前列腺癌的患者以及28名年龄匹配的健康个体纳入本研究。患者通过膀胱镜检查诊断,并对肿瘤进行组织病理学评估,以确定为浅表性或浸润性膀胱癌。对患者进行临床随访,记录与疾病复发和进展相关的数据。膀胱肿瘤纤连蛋白(BTF;ng/ml)通过为Immulite自动免疫分析系统(美国加利福尼亚州洛杉矶市诊断产品公司)开发的固相双位点化学发光免疫分析商业诊断试剂盒进行测定。所有测量值均通过尿肌酐进行标准化,所得数据通过受试者操作特征(ROC)曲线分析进行评估。最佳临界值设定为43.4 ng/mg。该临界值使总体灵敏度达到72%,特异性达到82.1%。BTF检测的分析评估在膀胱癌的非侵入性体外诊断方面显示出有前景的结果。尽管它在预测疾病复发或进展方面并不令人满意,但与最可靠的预后因素之一——分期密切相关。总之,尿液膀胱肿瘤纤连蛋白检测值得进一步进行临床评估。

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